K Number
K043046
Device Name
COOLTOUCH, MODEL CT3S
Date Cleared
2005-02-01

(89 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CoolTouch CT3S Nd:YAG Laser System is indicated: a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue, b) for use in the treatment of fine lines and wrinkles, c) for treatment of back acne and atrophic acne scars, d) for treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.
Device Description
The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optic, and/or the handpiece.
More Information

CTEV

Not Found

No
The summary describes a laser system with a microcontroller for control, but there is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.

Yes
The device is used for the treatment of various medical conditions such as fine lines and wrinkles, acne, and varicose veins, which are therapeutic applications.

No

The device description and intended use indicate it is a laser system used for treatments such as incision, excision, ablation, vaporization, and treatment of various conditions (fine lines, wrinkles, acne, varicose veins). There is no mention of it being used to diagnose any condition.

No

The device description explicitly states it consists of a cabinet housing hardware components (power supply, cooling system, microcontroller, laser), a fiber optic, and/or a handpiece, indicating it is a hardware-based medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
  • Device Description and Intended Use: The CoolTouch CT3S Nd:YAG Laser System is a laser device used for surgical procedures (incision, excision, ablation, vaporization), cosmetic treatments (fine lines, wrinkles, acne scars), and vascular treatments (varicose veins). These are all procedures performed on the body, not tests performed on samples taken from the body.
  • Lack of IVD-related information: The description does not mention any analysis of biological samples, reagents, or diagnostic assays, which are characteristic of IVDs.

Therefore, the CoolTouch CT3S Nd:YAG Laser System is a therapeutic and surgical device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The CoolTouch CT3S Nd:YAG Laser System is indicated:
a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue,
b) for use in the treatment of fine lines and wrinkles,
c) for treatment of back acne and atrophic acne scars,
d) for treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.

Product codes

GEX

Device Description

The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optic, and/or the handpiece.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Clinical trials also produced results that indicated that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities. See previous related 510(k) submissions for clinical results.
Nonclinical Performance Data: None

Key Metrics

Not Found

Predicate Device(s)

CoolTouch Corporation Model NS-160, CTEV.

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

0

CoolTouch Corporation Model CT3S Nd:YAG Laser System 510(k) Premarket Notification 510(k) SUMMARY

人 043046

Submitter:CoolTouch Corporation
Address:9085 Foothills Boulevard
Roseville, CA 95747
Contact Person:Donald V. Johnson
Vice-President of Operations
Telephone:(916) 677-1912
Facsimile:(916) 677-1901
Date Prepared:
Device Trade Name:CoolTouch Corporation Model CT3S Nd:YAG Laser
System
Common Name:Nd: YAG Surgical Laser
Classification Name:Laser Surgical Instrument.
21 C.F.R. § 878.4810
Legally Marketed Predicate Device:CoolTouch Corporation Model NS-160, CTEV.
Description of the CoolTouch
Nd:YAG Laser Systems:The CoolTouch Nd:YAG Laser Systems are Nd:YAG
lasers producing laser emission at 1320 nm. The lasers
consist of three interconnected sections: The cabinet,
which houses the power supply, cooling system,
microcontroller and the laser, the fiber optic, and/or the
handpiece.
Intended use of CoolTouch
Nd:YAG Laser Systems:The intended use of the CoolTouch CT3S Nd:YAG
Laser System is:
a) for use in dermatology for incision, excision, ablation
and vaporization with hemostasis of soft tissue,
b) for treatment of fine lines and wrinkles,
c) for treatment of back acne and atrophic acne scars,
d) for treatment of reflux of the greater saphenous vein
associated with varicose veins and varicosities.
Nonclinical Performance Data:None
Clinical Performance Data:Clinical trials also produced results that indicated that
the CoolTouch Nd:YAG Laser Systems are effective in
the treatment of reflux of the greater saphenous vein
associated with varicose veins and varicosities. See
previous related 510(k) submissions for clinical results.
Conclusion:The CoolTouch CT3S Nd:YAG Laser System is
indicated:
a) for use in dermatology for incision, excision, ablation
and vaporization with hemostasis of soft tissue,
b) for the treatment of fine lines and wrinkles,
c) for treatment of back acne and atrophic acne scars,
d) for treatment of reflux of the greater saphenous vein
associated with varicose veins and varicosities.
Additional Information:None requested at this time

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three overlapping lines, which represent the department's mission to protect the health of all Americans and provide essential human services.

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald V. Johnson Vice President of Operations CoolTouch Corporation 9085 Foothills Boulevard Roseville, California 95747

Re: K043046

Trade/Device Name: CoolTouch CT3S Nd:YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 21, 2005 Received: January 24, 2005

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererors, mans of the Act include requirements for annual registration, listing of general controls profice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rryour device is elassified (tools. Existing major regulations affecting your device can may be subject to suen adaterial evenlations. Title 21, Parts 800 to 898. In addition, FDA may be round in the over ments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean ITCase oc advised that I DTC issuantes syour device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must of ally it catal statutes und regalabents, including, but not limited to: registration and listing (2 h Comply with an the Hot 31equirements, and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Donald V. Johnson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your and inding of substantial equivalence of your device to a legally premaince notificated in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please ir you dome office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golferal micronal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

510(k) Number: __ K 04304b____________________________________________________________________________________________________________________________________________________

Device Name: CoolTouch CT3S Nd:YAG Laser System

Indications for Use:

The CoolTouch CT3S Nd:YAG Laser System is indicated:

a) for use in dermatology for incision, excision, ablation and vaporization with

hemostasis of soft tissue,

b) for use in the treatment of fine lines and wrinkles,

c) for treatment of back acne and atrophic acne scars,

d) for treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Pror (Division Sign-Off) Division of General, Restorative, and Neurological Devices KO 4 38ver-the-Counter Use_ OR Prescription Use 510(k) Number 1 CFR 801.109)